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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


ICH M9 BCS-Based Biowaivers

    Session Chair(s)
      Roger  Nosal, PhD

      Roger Nosal, PhD

      • Vice President, Global CMC
      • Pfizer Inc, United States
    The ICH M9 Expert Working Group has developed a preliminary draft of a harmonized guideline for BCS-Based Biowaivers that focuses on standardizing Biopharmaceutics Classification System criteria for demonstrating solubility, permeability/absorption, other pharmacological attributes and in vitro comparative dissolution. This session will provide a summary of the objectives for establishing a harmonized guideline that will be applicable globally and highlight current contentious issues to be resolved including: • Solubility: Highest Strength vs. Highest Therapeutic Dose • Permeability: Applicability of in vitro data (Caco-2) • Dissolution Comparability: Establishing Harmonized Conditions & Methodology Criteria • Formulation Similarity: Product Composition Applicability & Influence of Excipients This session will highlight regional challenges and differences and opportunities for harmonized reconciliation.
    Learning Objective : Describe the current challenges related to biowaivers and the progress and potential of the future ICH M9 guideline.
    Speaker(s)
      Roger  Nosal, PhD

      ICH M9 BCS Based Biowaivers: Progress and Challenges

      Roger Nosal, PhD

      • Vice President, Global CMC
      • Pfizer Inc, United States
      Paul  Seo, PhD

      Revisiting Classification Criteria for Demonstrating Solubility, Permeability, and Comparative Dissolution

      Paul Seo, PhD

      • Director, Division of Biopharmaceutics, ONDP, OPQ, CDER
      • FDA, United States
      Talia  Flanagan, PhD

      Regional Challenges for Comparative Dissolution and Post-Approval Changes: Excipients

      Talia Flanagan, PhD

      • Associate Principal Scientist, Biopharmaceutics
      • AstraZeneca, United Kingdom